Category: Personal Sound Amplification

Personal Sound Amplification

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FDA Issues Letter to “OTC Hearing Aid” Manufacturers

A letter by the FDA's William Maisel cautions that hearing devices cannot use “OTC hearing aids” in their marketing since the FDA definition of this hearing aid class—which would probably include severity of loss and other important safety, quality, and labeling requirements—has not yet been established.

IntriCon Reports Sales Increase of 28.5% in 2018

IntriCon, a major value-based hearing device and PSAP developer and manufacturer, announced revenues of $116.5 million in 2018, up 28.5% from $90.6 million in 2017. The company sees continued growth ahead, as its President and CEO Mark Gorder predicts FDA guidance on over-the-counter hearing devices by the end of this year, with final OTC regulations by the first half of 2020.

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Evaluating Select Personal Sound Amplifiers and a Consumer-Decision Model for OTC Amplification

OTC hearing devices are coming, but how should they function and for whom should they be recommended? Drs Ron Leavitt, Ruth Bentler, and Carol Flexer present six case studies showing that people with true moderate hearing loss may not be well served by what has been characterized as a “consumer-decides” model of care.

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Elite 2017 Business Summit Elevates Independents in Era of Disruptive Change

This year’s Summit theme was “Elevate Your Independence,” focusing on how independent hearing care professionals can succeed in an era of disruptive technology, distribution, and what may ultimately be a new regulatory environment. Included in the Summit’s General Session was a historical perspective on the current over-the-counter device proposals, as well as a review of a recent pilot study that supports professionally dispensed hearing aids over OTC.

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HIA Recommends OTC Hearing Devices Be Restricted to Mild Losses; Retain Consumer Safety and Efficacy Assurances

The Hearing Industries Association has recommended that, if the FDA creates a new over-the-counter (OTC) category for hearing devices, these products be confined to mild hearing losses and comply with the same safety and efficacy standards required for air-conduction hearing aids. Further, if the OTC category is established, HIA recommends that FDA review and finalize its guidance for PSAPs so these devices cannot be marketed to address hearing loss.

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